AWARE - Chronic Urticaria

NCT ID: NCT02435238

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-03

Study Completion Date

2017-09-27

Brief Summary

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Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.

Detailed Description

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Conditions

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Chronic Urticaria

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months.

Subject must be refactory to at least one H1 antihistamine

Exclusion Criteria

Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months.

Subjects taking must not take part in any other concurrent urticarial study.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Plymouth, Devon, United Kingdom

Site Status

Novartis Investigative Site

Darlington, Durham, United Kingdom

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Novartis Investigative Site

Leytonstone, London, United Kingdom

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Novartis Investigative Site

Salford, Manchester, United Kingdom

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Novartis Investigative Site

Coventry, Warwickshire, United Kingdom

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Novartis Investigative Site

Belfast, , United Kingdom

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Novartis Investigative Site

Belfast, , United Kingdom

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Novartis Investigative Site

Cardiff, , United Kingdom

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Novartis Investigative Site

Chester, , United Kingdom

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Novartis Investigative Site

Durham, , United Kingdom

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Novartis Investigative Site

East Yorkshire, , United Kingdom

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Novartis Investigative Site

Kent, , United Kingdom

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Novartis Investigative Site

Leeds, , United Kingdom

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Novartis Investigative Site

Leicester, , United Kingdom

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Novartis Investigative Site

Liverpool, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

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Novartis Investigative Site

Manchester, , United Kingdom

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Novartis Investigative Site

Manchester, , United Kingdom

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Novartis Investigative Site

Middlesbrough, , United Kingdom

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Novartis Investigative Site

Poole, , United Kingdom

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Novartis Investigative Site

Sheffield, , United Kingdom

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Countries

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United Kingdom

Other Identifiers

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CIGE025EGB01

Identifier Type: -

Identifier Source: org_study_id

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